The development of highly effective HIV prevention strategies, including a preventive vaccine and other non-vaccine biomedical prevention (nBP) products, remains one of the highest priorities for the Division of AIDS (DAIDS) and the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). With current global HIV infection estimates exceeding 33 million people, the development of safe, effective, and acceptable nBP products to prevent the sexual transmission of HIV could play a major role in the worldwide reduction of the estimated 5000 new HIV infections per day. As promising nBP products emerge (e.g., microbicides, pre-exposure prophylaxis (PrEP) agents, and Multipurpose Prevention Technologies (MPT?s), there is a critical need to rapidly and efficiently move these candidates into clinical testing. The scope of work encompasses preclinical activities that range from initial product discovery to those required to support clinical trials and/or product licensure. This activity will provide support for regulatory expertise in the development biotherapeutic agents and assist with filings with the U.S. Food and Drug Administration (FDA).